FDA issues EUA for NBA-funded COVID-19 saliva test

The U.S. Food and Drug Administration (FDA) on August 15 issued an Emergency Use Authorization (EUA) for a COVID-19 test resulting from an unusual research partnership between the Yale School of Public Health and the National Basketball Association.

The EUA was granted to Yale for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 infection. SalivaDirect does not require any special type of swab or collection device; a saliva sample can be collected in any sterile container.

This test is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past. Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources. Additionally, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs.

“The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Assistant Secretary for Health and COVID-19 Testing Coordinator Admiral Brett P. Giroir, MD. “Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic.”

Yale intends to provide the SalivaDirect protocol to interested laboratories as an “open source” protocol, meaning that designated laboratories could follow the protocol to obtain the required components and perform the test in their lab according to Yale’s instructions for use. Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country, provided they comply with the conditions of authorization in the EUA.

A study supporting the effectiveness of the test, published as a preprint paper on August 4, was funded in part by the NBA and its union, the NBA Players Association. The NBA and NBAPA contributed more than $500,000 to fund the validation study for SalivaDirect, according to ESPN.

In mid-May, the NBA approached the Yale team behind SalivaDirect, curious about a potential partnership that could help validate their university's new saliva-based assay, according to the Yale Daily News. The collaboration generated a plan to verify the test, as players from 22 of the NBA’s 30 teams embarked on their own experiment to recreate the season in a protective bubble.

According to the August paper, reagents for the SalivaDirect test could cost as little as $1.29 to $4.37 per sample. The researchers estimated that Proteinase K, used for sample processing, would cost somewhere between 13 and 26 cents a sample. Primers and probes would cost a few cents. And a RT-qPCR kit would require between 75 cents and $2.11 per sample.

When labs offer tests to the public, each test should only cost $10 or less, Anne Wyllie, a Yale associate research scientist in epidemiology who helped spearhead the research, wrote in an email to the News.

Read the FDA press release: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19...

Read the Daily News story: https://yaledailynews.com/blog/2020/08/15/fda-extends-emergency-use-auth...

Read the study: https://www.medrxiv.org/content/10.1101/2020.08.03.20167791v1.full.pdf